|
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.At least two wire guides were used during the procedure from different manufacturers; we are unable to confirm the device failure is associated with a wilson-cook medical wireguide.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined the instructions for use instruct the user to do the following: "prior to removing wire guide from holder, flush with 30 cc of sterile water." failure to flush the wire guide can result in damage to the wire guide.The instructions for use instruct the user to do the following: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, wire guide should be kept wet, if applicable." failure to flush the endoscope channel can result in damage to the wire guide.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide damage.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
|
|
The following was reported under med sun (b)(4): during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.It was reported that a patient transferred to our hospital [(b)(6) medical center] for endoscopic retrograde cholangiopancreatography (ercp) with endoscopic ultrasonography (eus) guidance after unsuccessful ercp at an outside hospital.Patient underwent ercp eus procedure and laparoscopic cholecystectomy, and discharged on postoperative day 4.Patient returned to the emergency department two days later and ct scan with contrast showed a foreign body in the right upper quadrant consistent with piece of retained wire.The patient underwent diagnostic laparoscopy with exploratory laparotomy for removal of foreign body.Patient was discharged home two days later.Other devices from separate manufacturers were also reported on this med sun form.It was reported that a piece of retained wire remained inside the patients body.The patient underwent diagnostic laparoscopy with exploratory laparotomy for removal of the foreign body.No further information was provided by the initial reporter, and it was not stated if the patient require any additional procedures or if the patient experience any adverse effects due to this occurrence.
|
